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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02338245




Registration number
NCT02338245
Ethics application status
Date submitted
6/01/2015
Date registered
14/01/2015
Date last updated
17/10/2017

Titles & IDs
Public title
Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab
Scientific title
Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy
Secondary ID [1] 0 0
ASLAN001-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASLAN001
Treatment: Drugs - Lapatinib
Treatment: Drugs - Capecitabine

Experimental: Treatment Arm A - ASLAN001 + Capecitabine

Active comparator: Treatment Arm B - Lapatinib + Capecitabine


Treatment: Drugs: ASLAN001
ASLAN001 400mg BID

Treatment: Drugs: Lapatinib
Lapatinib 1250mg QD

Treatment: Drugs: Capecitabine
Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the efficacy of ASLAN001 in combination with capecitabine, to lapatinib in combination with capecitabine in the percentage change from baseline tumor size at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events)
Timepoint [1] 0 0
estimated 2 years
Secondary outcome [2] 0 0
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by PFS and tumor volume
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by the Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS)
Timepoint [3] 0 0
2 years

Eligibility
Key inclusion criteria
* Patients with documented histological confirmation of breast cancer with HER 2 overexpression or gene amplification prior to study entry.
* Patients with HER 2-positive metastatic breast cancer that have failed on prior first line treatment with trastuzumab or who have progressed within 1 year of treatment with trastuzumab in adjuvant setting.
* Presence of at least one radiographically measurable disease (bone metastases and ascites are not considered measurable lesions).
* Patients of the respective country's legal age or older at the time of written informed consent.
* Patients with acceptable organ and hematological function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with radiation treatment or major surgical procedures within 21 days prior to study entry.
* Patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
* Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with any history of other malignancy unless in remission for more than 1 year. (Nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary).
* Patients with symptomatic central nervous system metastasis and/or on systemic steroids or anticonvulsants within 3 months before the first dose of randomized therapy.
* Patients who are pregnant or breast-feeding.
* Patients who were previously treated with ASLAN001 and/or with lapatinib.
* Patients who have received more than 2 lines of any therapies in metastatic stage.
* Patients who have received any investigational drug (or have used an investigational device) within 21 days or received any antineoplastic monoclonal antibodies within a period of 5 half-lives before receiving the first dose of randomized therapy.
* Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/08/2016
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australia - Western Australia
Recruitment postcode(s) [1] 0 0
6000 - Western Australia
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
Philippines
State/province [5] 0 0
Bacolod City
Country [6] 0 0
Philippines
State/province [6] 0 0
Dasmarinas
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taoyuan
Country [9] 0 0
Taiwan
State/province [9] 0 0
KaohSiung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taichung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
ASLAN Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.
Trial website
https://clinicaltrials.gov/study/NCT02338245
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02338245